Associate Director, Technical Operations (Small Molecule CMC)

Scorpion Therapeutics; United States; On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plan with company match

Generous paid time off

Job summary

Scorpion Therapeutics is seeking an Associate Director of Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at CDMOs in the United States. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to drive milestone achievement and lifecycle management.

You will review manufacturing documentation, support GMP systems, and author regulatory content while ensuring US/EU GMP alignment and strategic objectives for

Qualifications

• 8+ years in late-phase development, scale-up and commercialization.
• Expert knowledge of small molecule API process development and PPQ.
• Experience overseeing CDMOs and contract testing labs (global preferred).

Responsibilities

• Provide technical oversight of API production, scale up, and PPQ for solid oral drug products.
• Review manufacturing documentation: change controls, batch records, tech transfer, validation reports.
• Verify qualification and validation status of CDMO processes.
• Support GMP quality systems: deviations, CAPAs, regulatory submissions, inspections.
• Collaborate on CMC development, clinical supply, and lifecycle management.
• Author/review regulatory content (INDs, IMPDs, NDAs).
• Maintain knowledge of US/EU GMP and ICH guidelines.
• Review scope and timelines to meet objectives.

Skills

Strong communication

Attention to detail

Collaboration

Six Sigma

Travel willingness

Education

BS in chemistry/biochemistry/pharmaceutical science/chemical engineering or related life sciences

MS/PhD preferred

Tools

Process characterization

PPQ understanding

Job description

Position Summary: The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at Travere CDMOs. The role supports product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management of small molecule drug products. Partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and milestone achievement.

Responsibilities

• Provide technical oversight of API production, scale up, process characterization, and PPQ for solid oral drug products manufactured at CDMOs.
• Review/approve manufacturing documentation: change notifications, batch records, process development, tech transfer, process characterization, validation protocols/reports.
• Verify suitability, qualification, and validation status of processes at CDMOs and external laboratories.
• Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
• Collaborate to support CMC development, clinical supply, commercialization, and lifecycle management.
• Author/review technical documents and regulatory content (INDs, IMPDs, NDAs).
• Maintain knowledge of US/EU GMP, ICH guidelines, and regulatory expectations.
• Review scope, timelines, and deliverables to meet contractual, quality, and program objectives.

Education/Experience Requirements

• B.S. in chemistry/biochemistry/pharmaceutical science/chemical engineering or related life sciences (M.S./Ph.D preferred).
• 8+ years relevant experience emphasizing late-phase development, scale-up, and commercialization.
• Expert knowledge of small molecule API process development/characterization, PPQ, and commercialization for solid oral formulations.
• Experience overseeing CDMOs and contract testing labs (preferably global).
• Broad knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
• Experience preparing/reviewing CMC sections of IND/IMPD/NDA filings.

Additional Skills/Experience

• Strong communication, organizational, decision-making, collaboration, and attention to detail.
• Six Sigma/statistics knowledge plus.
• Travel 10-20% domestically/internationally.
• Ability to perform face-to-face/onsite work in San Diego; role not 100% remote.

Total Rewards Offerings (Benefits)

• Premium health, financial, work-life/well-being offerings; wellness and employee support programs; life insurance; disability; retirement plans with employer match; generous paid time off.